A Phase 3 interventional study of application of cream "La Chinata" in Dermatophytoses and Skin Lesion, sponsored by University of Extremadura. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by University of Extremadura · Phase 3, Interventional, and Treatment
Mycosis is defined as a fungal infection caused by the implantation of etiological agents that compromises the dermis and subcutaneous tissue.
Dermatophytosis is a fungal infection caused by dermatophytes, being the main cause of superficial mycoses and constituting an important public health problem.
The production or development of infections is due in any case to the loss of ability to protect the exterior of the skin epidermis and, in the case of nails, to the fact that the nail apparatus does not have cell-mediated immunity effective, thus being more susceptible to infection than other parts of the skin. Although these infections can be bacterial, fungal, or viral, the investigators will focus on fungal infections.
There are numerous studies that suggest the suitability of EOs as an alternative treatment for fungal infections.
Due to this, in this project the investigators will analyze one of the most important infections within the podiatric health of the population, in terms of its incidence, pathogenesis, diagnostic methods, etc., and for this our research will be focused on examining whether there is improvements in the skin of patients with dermatophytosis treated with cream enriched with natural oils, in our case tea tree oil, verified by ultrasound.
Mycosis is defined as a fungal infection caused by the implantation of etiological agents that compromise the dermis and subcutaneous tissue. The etiological agents can be filamentous fungi, yeasts and mold fungi, present in nature, in the soil, vegetation and in decomposing organic matter. Mycosis is among the most common form of infection in humans, with an approximate incidence of 20-25% of the world population.
Dermatophytosis is the fungal infection caused by dermatophytes, being the main cause of superficial mycoses and constituting an important public health problem. Dermatophytes are divided into three genera, having an affinity for and the ability to grow in keratinized tissues, such as hair, skin, and nails. Other fungal infections of the skin and appendages in humans may be caused by non-dermatophyte fungi, such as yeasts and mold fungi. Onychomycosis is dermatophytosis that affects the nails, this being one of the most frequent causes in the clinic, both in the dermatological field and in general medicine. In this type of infections, the most important thing is to know the agent that causes the infection, thus being able to establish a specific treatment. Currently, approximately 90% of toenail onychomycosis and 75% of all nail onychomycosis are caused by dermatophytes. The production or development of infections is due in any case to the loss of ability to protect the exterior of the skin epidermis and, in the case of nails, to the fact that the nail apparatus does not have cell-mediated immunity effective, thus being more susceptible to infection than other parts of the skin. Although these infections can be bacterial, fungal, or viral, the investigators will focus on fungal infections.
Various scientific articles have verified and confirmed that superficial fungal infection (tinea pedis, athlete's foot, tinea versicolor, etc.) is usually referred to the foot, due to its transmission through showers and shared materials, environmental humidity , etc.
There are numerous studies that suggest the suitability of EOs as an alternative treatment for fungal infections and the investigators found numerous studies that demonstrate the antifungal action of various commercial EOs in in vitro studies. Among the most studied EOs due to their antifungal activity, the following stand out: thyme (Thymus vulgaris), cinnamon (Cinnamomun zeylanicum) and tea tree (Melaleuca alternifolia), among many others.
Due to this, in this project we will analyze one of the most important infections within the podiatric health of the population, in terms of its incidence, pathogenesis, diagnostic methods, etc., and for this our research will be focused on examining whether there is improvements in the skin of patients with dermatophytosis treated with cream enriched with natural oils, in our case tea tree oil, verified by ultrasound.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's enrollment of 49 is below the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
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Ultrasound skin measurements will be taken before and after the enriched cream treatment.
Measurements of the skin will be taken by "Visiopor PP-34" camera before and after the treatment with enriched cream.
Skin samples will be taken and analyzed by mycological culture before and after treatment with enriched cream
The essential oil enriched cream will be applied to study participants.
Combination Product: application of cream "La Chinata"
application of cream enriched with essential oil
Appearance of the skin through the use of ultraviolet light through the processing of photographs obtained
Data collection with Visiopor camera. Measurement unit: occupied area
Time frame: 3 months
Skin thickness measured in millimeters through images obtained by ultrasound
Data collection with ultrasound. Measurement unit: millimeters
Time frame: 3 months
Taking mycological samples for subsequent cultivation on saboureaud agar
take mycological samples to check for infection. Measurement unit: positive/negative
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2023 to primary completion in Nov 2023, 9 months.
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University of Extremadura